Home NDC 16714-403 Cefpodoxime Proxetil
Product NDC 16714-403
11-digit product format 167140403
Labeler code 16714
Product ID 16714-403_3c3d4973-bfda-476f-b094-52ac4648d7f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefpodoxime Proxetil
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA065409
Marketing category ANDA
Marketing start 2007-06-08
Substance CEFPODOXIME PROXETIL
Active strength 100 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065409-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 A065409-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Cefpodoxime Proxetil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFPODOXIME PROXETIL 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2TB00A1Z7N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309077 Internal RxNorm lookup 309079 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-403-01 Cefpodoxime Proxetil 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 7 16714-403-01 Cefpodoxime Proxetil 50 mL in 1 BOTTLE GRANULE, FOR SUSPENSION 50 7 16714-403-02 Cefpodoxime Proxetil 100 mL in 1 BOTTLE GRANULE, FOR SUSPENSION 100 7 16714-403-02 Cefpodoxime Proxetil 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPODOXIME PROXETIL ACTIVE INGREDIENT 2TB00A1Z7N CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 CEFPODOXIME ACTIVE MOIETY 7R4F94TVGY CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-403 CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [NORTHSTAR RX LLC] 7 Current NDC, Legacy NDC, 4 package rows 20240105_5310de78-22c3-4bee-9956-854e767b6bef.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16714-403-01 16714040301 1 BOTTLE in 1 CARTON (16714-403-01) / 50 mL in 1 BOTTLE 1 bottle 2007-06-08 0000-00-00 No No Current 16714-403-02 16714040302 1 BOTTLE in 1 CARTON (16714-403-02) / 100 mL in 1 BOTTLE 1 bottle 2007-06-08 0000-00-00 No No Current